# K140055: Endoskeleton (R) TL Interbody Fusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Titan Spine, LLC
- Decided: Jul 2, 2014 after 173 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003275 (2001). 22 ancestors in all.
267 later devices descend from it; 3 cite it directly.
0 of 290 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102067: Endoskeleton to, Titan Spine, LLC (2010) Summary page 2.
- K032812: Endoskeleton TA Vertebral Body Replacement, Orthovita, Inc. (2003) Summary page 2.
- K071795: Nuvasive Coroent System, Nuvasive, Inc. (2007) Summary page 2.

## Most influential descendants
- K141953: Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TL (2014), 265 descendants of its own
- K152475: FORZA PTC Spacer System (2016), 236 descendants of its own
- K153495: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System (2016), 189 descendants of its own
- K162103: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™) (2016), 161 descendants of its own
- K163269: Endoskeleton (R) TAS Interbody Fusion Device / Endoskeleton (R) TAS Hyperlordotic Interbody Fusion Device (2017), 143 descendants of its own

## Indications for use
The Endoskeleton®g TL IBO is indicated for use in spinal fusion procedures in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S 1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. This device is intended for use with supplemental fixation systems cleared for use in the lumbar spine. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients with non-fusion spinal surgery at the involved level(s) may be treated with the device. It is indicated to be used with autograft bone.

Source page: https://510kreport.com/device/K140055
Methodology: https://510kreport.com/methodology